Pfizer recently submitted trial data to the Food and Drug Administration for Chantix — a drug intended to help its users quit smoking — in the hopes the agency would remove a serious warning from the drug's label. Instead, the FDA expressed concerns over the collection and interpretation of the study data, reported Reuters.
Pfizer seeks to remove the "black box" warning — which highlights psychiatric risks like suicidal thoughts, hostility and agitation — from Chantix's label. In March 2015, an advisory committee encouraged the FDA to wait for results from an 8,000-person study of the drug before deciding whether to remove the warning or not.
In the study, researchers compared the effects of Chantix or GlaxoSmithKline's Zyban to a placebo or nicotine patch in smokers with and without a history of psychiatric disorders, according to the report. Results showed Chantix did not significantly increase the amount of psychiatric side effects in users. However, the FDA highlighted inconsistencies in data collection and the characterization of several side effects, saying these factors may have caused biased results.
A group of independent advisors will discuss the study's findings on Wednesday to decide whether or not the FDA should remove the warning. While the agency is not forced to follow the panel's recommendations, it usually does.
New York City-based Pfizer launched Chantix in 2006. The drug, which loses patent exclusivity in four years, produced $671 million in 2015 global sales.
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